Monural

Leaflet attached to the packaging: patient information

MONURAL

2 g, granules for oral solution

Fosfomycin trometamol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Monural and what is it used for
• 2. Important information before taking Monural
• 3. How to take Monural
• 4. Possible side effects
• 5. How to store Monural
• 6. Contents of the packaging and other information

1. What is Monural and what is it used for

Monural is a broad-spectrum antibiotic used to treat urinary tract infections.
The bactericidal mechanism of action of fosfomycin (the active substance) involves disrupting the synthesis of the bacterial cell wall. The specific mechanism of action means that bacteria resistant to other antibiotics do not develop resistance to fosfomycin (no cross-resistance). Monural is effective against Gram-positive and Gram-negative bacteria most commonly found in urinary tract infections: E. coli, Citrobacter spp., Klebsiella spp., Proteus spp., Serratia spp.
Monural is rapidly absorbed from the gastrointestinal tract, although food may delay absorption and slightly decrease the maximum concentration of fosfomycin in blood and urine. However, the concentration remains within the therapeutic range. Fosfomycin penetrates the kidneys, bladder wall, prostate, and seminal vesicles. It achieves particularly high concentrations in urine, with which it is excreted in its active form. After 24-48 hours of oral administration, the concentration of fosfomycin in urine remains above the minimum inhibitory concentration for bacteria.
Fosfomycin may reduce the adhesion of bacteria to the bladder mucosa, a factor that contributes to the occurrence of recurrent infections.
Monural 2 g is used in children over 5 years of age for the following indications:

• treatment of acute uncomplicated bacterial cystitis;
• treatment of asymptomatic bacteriuria (large amounts of bacteria in the urine);
• prevention of urinary tract infections associated with surgical procedures and diagnostic procedures performed through the urethra.

2. Important information before taking Monural

When not to take Monural:

• in patients with severe renal impairment (when creatinine clearance is less than 10 ml/min);
• in patients undergoing hemodialysis.

Warnings and precautions

Before starting treatment with Monural, the patient should discuss it with their doctor or pharmacist.
During treatment with Monural, allergic reactions (hypersensitivity) to the active substance may occur, including anaphylactic reaction and anaphylactic shock, which can be life-threatening (see section 4 "Possible side effects"). If the patient experiences such a reaction, they should receive appropriate treatment, and fosfomycin should never be taken again.
The use of almost any antibacterial medicine, including fosfomycin, is associated with the occurrence of diarrhea. The severity of diarrhea can range from mild to life-threatening colitis.
If the patient experiences severe, persistent diarrhea and/or bloody stools during or after treatment with fosfomycin (even up to several weeks after treatment), they should contact their doctor immediately, who will provide appropriate treatment. In such cases, the patient should not take medicines that inhibit intestinal peristalsis.

Children

Monural 2 g is intended for use in children over 5 years of age.

Monural and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Studies evaluating the interaction of this medicine with other medicines have been conducted only in adults.
It has been shown that concomitant use of fosfomycin and metoclopramide reduces the concentration of fosfomycin in serum and urine. Other medicines that accelerate intestinal motility may have a similar effect.
Monural, like other antibiotics, may affect the blood coagulation index (INR) in patients taking vitamin K antagonist medicines (anticoagulants) at the same time.

Monural with food and drink

Food may delay the absorption of Monural, resulting in a slight decrease in the maximum concentration of fosfomycin in blood and urine. Therefore, it is recommended to take Monural on an empty stomach or 2-3 hours after a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The doctor will decide whether to use the medicine.
Pregnancy
It is believed that antibiotic therapy involving a single dose is not suitable for the treatment of urinary tract infections in pregnant women.
During pregnancy, Monural should be used only when absolutely necessary and always under close medical supervision.
Breastfeeding
Fosfomycin passes into breast milk in small amounts.
During breastfeeding, Monural should be used only when absolutely necessary and always under close medical supervision.

Driving and using machines

The effect of Monural on the ability to drive and use machines has not been studied. After taking the medicine, dizziness has been reported, which may affect the ability to drive and use machines. If dizziness occurs, the patient should not drive or operate machines.

Monural contains sucrose

One sachet contains 2.1 g of sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Monural

This medicine should always be taken exactly as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Recommended dosage

• The usual dose of Monural for children over 5 years of age is: 1 sachet (2 g) as a single dose.
• In urinary tract infections in hospitalized children and in recurrent or complicated infections caused by Pseudomonas spp., Enterobacter spp., Proteus spp., it is recommended to administer a second dose of the medicine (2 g) after 24 hours. Usually, the symptoms of the infection disappear on the 2nd or 3rd day of treatment.
• In the prevention of urinary tract infections associated with surgical procedures, it is recommended to administer two doses (1 sachet each). The first dose should be given 3 hours before the procedure, and the second dose 24 hours after the procedure.

Do not take more than the recommended dose.
Method of administration
Monural is taken orally 2-3 hours after a meal, preferably before bedtime and after emptying the bladder. The contents of the sachet should be dissolved in 50-75 ml of water and taken immediately after preparation.

Taking more than the recommended dose of Monural

In case of overdose, the patient should increase the excretion of the medicine with urine by drinking plenty of fluids. They should immediately consult their doctor or pharmacist, taking the packaging of the medicine with them.

Missing a dose of Monural

If a dose is missed, the patient should not take a double dose to make up for the missed dose. The next dose should be taken at the time resulting from the recommended dosing schedule.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Monural can cause side effects, although not everybody gets them.
The most common side effects after a single dose of fosfomycin trometamol are related to the gastrointestinal system, mainly diarrhea. These events are usually temporary and resolve on their own.
Side effects are listed by frequency of occurrence.
Common(occurring in less than 1 in 10 people): vulvovaginitis, headache, dizziness, diarrhea, nausea, dyspepsia.
Uncommon(occurring in less than 1 in 100 people): paresthesia (sensory disturbances), vomiting, abdominal pain, rash, urticaria, itching, fatigue.
Rare(occurring in less than 1 in 1000 people): tachycardia (rapid heart rate).
Frequency not known(cannot be estimated from the available data): anaphylactic reactions, including anaphylactic shock (a generalized allergic reaction with a sudden and severe course), hypersensitivity reactions, asthma, antibiotic-associated colitis, angioedema (swelling that usually occurs in the face or throat and can be life-threatening), hypotension.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel. + 48 22 49 21 301, fax: + 48 22 49 21 309, e-mail: [email protected]
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Monural

There are no special precautions for storage.
The medicine should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Monural contains

The active substance is fosfomycin (in the form of fosfomycin trometamol).
1 sachet contains 6 g of granules, including 2 g of fosfomycin in the form of fosfomycin trometamol (3.754 g).
The other ingredients are: tangerine flavor, orange flavor, saccharin, sucrose.

What Monural looks like and what the pack contains

Monural is a granule for oral solution.
The immediate packaging is a sachet made of paper/PE/Aluminum/PE.
Packaging: 1 sachet in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

ZAMBON S.p.A.
Via Lillo del Duca, 10
20091 Bresso (MI), Italy

Manufacturer

ZAMBON S.p.A.
Via della Chimica 9
36100 Vicenza, Italy

Representative of the marketing authorization holder

Angelini Pharma Polska Sp. z o.o.
ul. Podleśna 83, 05-552 Łazy
tel. 22 70 28 200
email: [email protected]
The patient leaflet in a format suitable for the blind and visually impaired is available at the representative's office.

Date of last revision of the leaflet: